The invention relates generally to the field of sampling and storing specimens collected from a patient, which can occur in the setting of a clinical trial or routine patient care. Medicine is becoming increasingly personalized, where molecular markers of disease (biomarkers) promise to detect conditions earlier and with more precision. Samples of blood and body fluids, as well as accurate clinical data are crucial to bring these advances to individual patients. Despite the importance of sampling, automating patient sampling and data collection is not widely practiced. Even in the most sophisticated clinical trials, data is still obtained manually and samples are still collected by hand. Collection methods can vary from hospital to hospital and the lack of standardized methods invites errors. Worldwide costs for the collection and storage of clinical specimens are in the hundreds of millions of dollars. More importantly, the study of diseases and biomarkers are not advancing due to the lack of availability of quality samples.
The expense of manually collecting patient data and samples for clinical trials is not trivial. Research coordinators, often nurses, must obtain or oversee the obtaining of samples, perhaps multiple times per day. A data collector must search the medical record and transcribe the data, often interfacing with multiple computer systems. The cost and labor requirements for clinical trials are confining them to the larger hospitals and academic centers, or sending them overseas where costs are lower. This has led to a gradual erosion of the credibility of clinical trial results due to their questionable applicability to most community-based clinicians, who have different local practices and different patient populations. There is a general lack of cost effective tools for conducting patient research in community hospitals. Approximately 4500 out of 5000 hospitals in the U.S. are community hospitals and that is where most patients receive health care.
The vast majority of clinical samples taken in clinical trials and medical practice are blood and urine samples. These come with a significant time commitment. Blood must be drawn either by sticking a vein with a needle, which can be very difficult in some patients, or by removing it from an intravascular catheter, using an appropriate sterile technique. Urine samples are often removed from a urine collection system, again using a sterile technique. There is a practical limit to how often these samples can be taken. Furthermore, there is a growing interest in obtaining other body fluids such as interstitial fluid from under the skin, from the brain, wounds, and transplanted organs, as well as cerebrospinal fluid, pleural fluid, ascites, and other body fluids. The technique of microdialysis, which can take continuous microliter sized samples from all of these sites, remains largely a research tool. The inconvenience of bulky fraction collectors, manually switching out of tubes, and problems with evaporation during microdialysis have all limited it largely to the realm of research.
Due to these limitations, current patient data collection and sampling methods are time consuming, expensive, and limited in how often and what they can sample. It would therefore be advantageous to develop an automated sampling and data collection system that is capable of sampling multiple body sites and collecting high volumes of data.